Nicotine Delivery Systems: Research & Treatment

NCT00108342 | Terminated Results

• 1 other identifier: NEUA-015-07S
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether sampling nicotine replacement treatments (NRTs) is superior to learning about them by computer. Testing also covers preferences among the treatments. Subjects will be enrolled veterans who smoke. Hypothesis: Direct experience ("sampling") of NRTs will increase knowledge about NRTs, motivation/confidence, use of NRTs and quit attempts in contrast to learning about NRTs by computer.

Conditions

Smoking

Keywords

nicotine; drug therapy; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Quit Attempts, Use of NRTs, Preference Among NRTs

  In addition to quit attempts, use of NRTs, and preference among NRTs, we also planned to assess learning and changes in motivation at all visits. Unfortunately, the study was terminated due to common comorbidities among the Veterans that precluded entry into the study. Due to the consequent small sample size, we did not analyze any data.

  At testing, at follow-up

Study Arms (2)

Nicotine Replacement Treatment (NRT) Sampling

ACTIVE COMPARATOR

Sampling = 3 minute testing of each of 6 NRTs (3 forms x 2 dosages) 2 mg and 4 mg nicotine gum; 2 mg and 4 mg nicotine lozenges; frequent and infrequent puffing on a nicotine inhaler (can yield 4 mg from 10 mg device).

Drug: Nicotine gum - 2 mg and 4 mg; Drug: Nicotine lozenges - 2 mg and 4 mg; Drug: Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing

NRT Computer Learning

SHAM COMPARATOR

Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only

Other: Computer learning

Interventions

Nicotine gum - 2 mg and 4 mg DRUG

Also known as: Nicorette gum

Nicotine Replacement Treatment (NRT) Sampling

Nicotine lozenges - 2 mg and 4 mg DRUG

Also known as: Nicorette Commit lozenges

Nicotine Replacement Treatment (NRT) Sampling

Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing DRUG

can yield 4 mg from 10 mg device - infrequent and frequent puffing

Also known as: Nicotrol

Nicotine Replacement Treatment (NRT) Sampling

Computer learning OTHER

NRT Computer Learning

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be enrolled veteran who smokes.

You may not qualify if:

• Any event or condition that could be exacerbated by the local effects of nicotine treatments (e.g., throat or stomach problems; any kind of wheezing from a condition or medication)
• other criteria as determined by PI and study physicians
• reactions to menthol (inhaler) or to aspartame (lozenge)

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Nicotine Chewing Gum; Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Therapeutics; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Limitations of the study: early termination of the study occurred due to widespread comorbidities precluding recruitment and enrollment of Veterans in this NRT trial. Specifically, the sample size was too small for any data analyses.

Results Point of Contact

• Title: Nina G. Schneider, Ph.D., Principle Investigator
• Organization: Department of Veterans Affairs - VAGLA

ngs@ucla.edu

310-268-3059

Study Officials

• Nina G. Schneider, PhD

  VA Greater Los Angeles Healthcare System, West LA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2005
• First Posted: April 15, 2005
• Study Start: October 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 4, 2014
• Results First Posted: June 4, 2014

Record last verified: 2014-06

Locations

US (1)